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CompletedNCT04395599COELIOCOVIDUpdated Dec 23, 2025

Risk of Air Contamination During Visceral Surgery in COVID19 Patients

An interventional study of Cartography of air contamination, environment contamination and biological fluid by Sars-Cov2 during visceral surgery in COVID19 patients. in Sars-CoV2, Surgery and COVID, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-23.

Sponsored by University Hospital, Lille · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
2
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Sars-Cov2 has been found in the digestive tract, as well as the respiratory tract. Protection of health care workers during surgery has been increased and some guidelines advocate for abandoning laparoscopy in COVID19 patients for fear of contamination, evenghtough this does not benefit the patient. However, Sars-Cov2 contamination risk during visceral surgery remains unknown. Inadequate protection is unnecessary costful and can be inefficient if too binding. Our hypotheses are that 1) Sars-Cov 2 can travel through droplet and air during visceral surgery. 2) Laparoscopy, because of the pneumoperitoneum and its leaks, warrant more air contamination whereas laparotomy warrant more droplet contamination, which would justified increased protection.

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Conditions studied

  • Sars-CoV2
  • Surgery
  • COVID

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Keywords

  • COVID-19
  • visceral surgery
  • air contamination
  • laparoscopy, prevention
  • prevention
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In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 2 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Documented Sars-Cov2 infection (nasopharyngeal swab, tracheal sampling, thoracic CT, serology)
  • Need of visceral surgery (laparoscopy or laparotomy)
  • Signed informed consent
  • Social coverage
  • Patient who agrees to be included in the study and who signs the informed consent form
  • Patient affiliated to a healthcare insurance plan
  • Patient willing to comply with study's requirements

Exclusion criteria

Exclusion Criteria:

  • Need of another type of surgery during the same procedure
  • Mentally unbalanced patients, under supervision or guardianship
  • Patient who does not understand French/ is unable to give consent
  • Patient not affiliated to a French or European healthcare insurance
  • Patient incarcerated
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    COVID19 patients undergoing visceral surgery

    Other: Cartography of air contamination, environment contamination and biological fluid by Sars-Cov2 during visceral surgery in COVID19 patients.

Interventions

  • OtherCartography of air contamination, environment contamination and biological fluid by Sars-Cov2 during visceral surgery in COVID19 patients.

    Air sampling, operating room surfaces sampling and patients' biological fluid sampling for Sars-Cov2 quantification

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What researchers measure

Primary outcomes

  1. Air contamination

    Composite criteria: "50cm above the operating site" and/or "1m50 from the operating site" and/or "3m from the operating site"

    Time frame: 10 minutes after incision if no opening of the digestive lumen, or 10 minutes after opening of the digestive tract

Secondary outcomes

  1. Environment contamination

    Cartography of Sars-Cov2 environment surface contamination

    Time frame: At the end of surgery, an average 1 hour 30 min

  2. Surgical approach

    Composite criteria: air contamination or environment contamination positivity rate according to surgical approach (laparoscopy or laparotomy)

    Time frame: At the end of the intervention, an average 2 hours

  3. Opening of the digestive tract

    Composite criteria: air contamination or environment contamination positivity rate according to opening of digestive tract status (opened or not)

    Time frame: At the end of the intervention,an average 2 hours

  4. Biological fluids

    Cartography of Sars-Cov2 presence in biological fluids (blood, stools, peritoneal fluid, digestive fluids, sputum, bile)

    Time frame: During the procedure, an average 2 hours 30 min

  5. Pneumoperitoneum

    Presence of Sars-Cov 2 in pneumoperitoneum, evaluated on surgical smoke filter

    Time frame: At the end of the procedure,an average 2 hours 30 min

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Study locations

1 site
  • Hop Claude Huriez Chu Lille
    Lille, 59037, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04395599
Lead sponsor
University Hospital, Lille
Responsible party
Sponsor
First posted
May 20, 2020
Start date
Nov 16, 2021
Primary completion
Jan 27, 2022
Completion
Jan 27, 2022
Last update
Dec 23, 2025

Study contacts

Robert CAIAZZO, MD,PhD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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